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Diss Factsheets

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well performed GLP and OECD guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Acetoacetanilide
EC Number:
202-996-4
EC Name:
Acetoacetanilide
Cas Number:
102-01-2
Molecular formula:
C10H11NO2
IUPAC Name:
3-oxo-N-phenylbutanamide
Details on test material:
- Name of test material (as cited in study report): Acetessiganilid TTR (Acetessiganilid, N-Acetoacetylaminobenzol)

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
- Source: Hoechst AG, Kastengrund, conventional breed
- Identification: numbered Earmarks
- Weight: 2.3 - 3.1 kg
- Age: 3 - 5 months
- Caging: single cages in air-conditioned rooms
- Temperature: 20 +/- 3 °C
- Humidity: 50 +/- 20 %
- Artificial light: 12 hrs daily
- Diet: Altromin 2123, ad libitum, as well as hay (about 15 g daily)
- Water: deionised, chlorinated water from automatic feeders

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
physiological saline
Controls:
not required
Amount / concentration applied:
- 500 mg of test substance mixed with 0.4 ml 0.9% NaCl solution
Duration of treatment / exposure:
4 hrs, the remaining test substance was removed with lukewarm tap water at the end of the exposure period
Observation period:
examinations were done at 30-60 min, 24, 48 and 72 hrs after exposure
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
other: animal # 1, 2, 3 each
Time point:
other: mean of 24, 48, 72h
Score:
0
Reversibility:
other: no signs of irritation at any time
Irritation parameter:
edema score
Basis:
other: animal # 1, 2, 3 each
Time point:
other: mean of 24, 48, 72 h
Score:
0
Reversibility:
other: no signs of irritation at any time

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Based on the findings in this test the test substance is neither skin irritating nor skin corrosing.
Executive summary:

Acetessiganilid TTR was tested for skin irritating or skin corrosive properties according to OECD 404. Following this protocol 500 mg of the test substance mixed with 0.4 ml physiol saline were applied to the shaved skin of 3 New Zealand White Rabbits. After 4 h exposure time the semiocclusive covering was removed and animals were periodically examined for signs of skin irritation or skin corrosion. Mean scores (mean of 24, 48, and 72 h) were calculated for edema and erythema for each rabbit.

Based on the findings in this test the test substance is neither skin irritating nor skin corrosing.